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RECRUITING

NCT06540833

PHASE2

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

Sponsor: Intra-Cellular Therapies, Inc.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2024-08-15

Completion Date

2028-12-29

Last Updated

2026-07-06

Healthy Volunteers

Conditions

Psychosis Associated With Alzheimer's Disease

Interventions

DRUG

ITI-1284

ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

DRUG

Placebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Inclusion Criteria: 1. Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \[LAR\]) before the initiation of any study-specific procedures in accordance with local regulations; 2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either: 1. Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or 2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan; 3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline; 4. Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline; 5. CGI-S score ≥ 4 at Screening and Baseline; 6. Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures; 7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver); Exclusion Criteria: 1. Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions: 1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia; 2. Bipolar disorder; 2. Risk for suicidal behavior during the course of their participation in the study or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening; 3. The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee, 4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia 5. The patient is bedridden or has any significant medical condition that is unstable and would either: 1. Place the patient at undue risk from study drug or undergoing study procedures; or 2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study; 6. The patient is in hospice or end-of-life care;

Locations (65)

Advanced Research Center, Inc

Anaheim, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Wr Pri Llc

Newport Beach, California, United States

ATP Clinical Research

Orange, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

Envision Trials LLC

Bonita Springs, Florida, United States

Clinical Research of Brandon

Brandon, Florida, United States

Healthcare Innovations Institute Inc

Coral Springs, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Science Connections LLC

Doral, Florida, United States

Homestead Associates in Research Inc

Homestead, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Wellness Research Center

Miami, Florida, United States

Ocean Blue Medical Research Center Inc.

Miami, Florida, United States

Allied Biomedical Research Institute (ABRI), Inc

Miami, Florida, United States

South Florida Research Phase I-IV

Miami, Florida, United States

Sunshine Medical Solution

Miami, Florida, United States

Combined Research Orlando

Orlando, Florida, United States

Intercoastal Medical Group

Sarasota, Florida, United States

University of South Florida

Tampa, Florida, United States

Psych Me Medical Research Inc

Tampa, Florida, United States

Bio Behavioral Health

Toms River, New Jersey, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Horizon Clinical Research Group

Cypress, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Medical Center Sv Dimitar Blagoevgrad

Blagoevgrad, Bulgaria

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

Cherven Bryag, Bulgaria

Mental Health Centre Prof. N Shipkovenski EOOD

Sofia, Bulgaria

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Intermedica, OOD

Sofia, Bulgaria

UMHAT Prof. Dr. St. Kirkovich AD

Stara Zagora, Bulgaria

Mental Health Center - Vratsa EOOD

Vratsa, Bulgaria

Polyclinic Neuron

Zagreb, Croatia

University Hospital Centre Zagreb 1

Zagreb, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

Psychiatric Clinic "VRAPCE"

Zagreb, Croatia

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Neuro Health Centrum s r o

Brno, Czechia

NEUROHK s r o

Hradec Králové, Czechia

INEP medical s.r.o.

Prague, Czechia

Przychodnia Srodmiescie SP. z o.o.

Bydgoszcz, Poland

Neuro Care

Katowice, Poland

Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu

Ścinawa, Poland

Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'

Bucharest, Romania

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1

Bucharest, Romania

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

Bucharest, Romania

Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian

Bucharest, Romania

Spitalul De Psihiatrie Elisabeta Doamna Galaţi

Galati, Romania

SC Carpe Diem SRL

Sibiu, Romania

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, Serbia

Special Hospital for Psychiatric Diseases Kovin

Kovin, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

University Clinical Center NIS

Niš, Serbia

Special Hospital for Psychiatric Diseases Sveti Vracevi

Novi Kneževac, Serbia

Neurologicka ambulancia MUDr.Dupejova s.r.o.

Banská Bystrica, Slovakia

Univerzitna nemocnica Bratislava

Bratislava, Slovakia

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Epamed sro

Košice, Slovakia

NEURES s r o

Krompachy, Slovakia

Crystal Comfort s.r.o.

Vranov nad Topľou, Slovakia

Hosp. Gral. de Albacete

Albacete, Spain

Hosp. Prov. de Zamora

Zamora, Spain

Hosp. Viamed Montecanal

Zaragoza, Spain

Clinical Research Directory

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (65)